BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WANDA¿

    MDR report key: 3030803 · Received April 2, 2013

    Report

    Report Number
    2134265-2013-01913
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER.(B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A VISUAL EXAMINATION OF THE ENTIRE DEVICE IDENTIFIED NO ISSUES. THE BALLOON WAS EXAMINED MICROSCOPICALLY AND NO TEARS OR HOLES WERE FOUND THE IN THE BALLOON MATERIAL. THE DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT AND THE BALLOON WAS INFLATED TO ITS RATED BURST PRESSURE WITH NO LEAKS NOTED. A VACUUM WAS PULLED AND THE BALLOON DEFLATED FULLY. THIS PROCESS OF INFLATING AND DEFLATING THE BALLOON FROM ITS RATED BURST PRESSURE WAS PERFORMED THREE MORE TIMES. THE BALLOON INFLATED AND MAINTAINED PRESSURE WITH NO LEAKS NOTED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS NOT CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, A BALLOON RUPTURE OCCURRED. ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 100% STENOSED LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS LEFT EXTERNAL ILIAC ARTERY. A NON-BSC GUIDE WIRE CROSSED THE LESION AND A 5.0 X 40MM WANDA BALLOON CATHETER WAS USED TO PRE-DILATE THE LESION AT 6ATMS. FOLLOWING PRE-DILATATION, A NON-BSC STENT WAS PLACED. THE 6.0 X 20MM WANDA BALLOON CATHETER WAS BEING USED FOR POST-DILATATION WHEN IT RUPTURED AT 10ATMS ON THE FIRST INFLATION. THE RUPTURED BALLOON WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH THE 5.0 X 40MM WANDA BALLOON CATHETER USED FOR PRE-DILATION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, A BALLOON RUPTURE OCCURRED. ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 100% STENOSED LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS LEFT EXTERNAL ILIAC ARTERY. A NON-BSC GUIDE WIRE CROSSED THE LESION AND A 5.0 X 40MM WANDA BALLOON CATHETER WAS USED TO PRE-DILATE THE LESION AT 6ATMS. FOLLOWING PRE-DILATATION, A NON-BSC STENT WAS PLACED. THE 6.0 X 20MM WANDA BALLOON CATHETER WAS BEING USED FOR POST-DILATATION WHEN IT RUPTURED AT 10ATMS ON THE FIRST INFLATION. THE RUPTURED BALLOON WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH THE 5.0 X 40MM WANDA BALLOON CATHETER USED FOR PRE-DILATION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134175 WANDA¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H965SCH505330 0015120770

    Patients

    Seq Age Sex Outcome Treatment
    1 STENT: 8MM×60MM S.M.A.R.T. (CORDIS)| GUIDEWIRE: .035 RADIFOCUS (TERUMO)| BALLOON CATHETER: WANDA 5MM×40MM (BSC)